Kidney Transplantation Clinical Trial
Official title:
A Phase 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
| Verified date | December 2023 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation. This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil (MMF), and steroids [calcineurin inhibitor (CNI) avoidance] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and steroids [CNI minimization-MMF avoidance] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids).
| Status | Completed |
| Enrollment | 149 |
| Est. completion date | January 27, 2017 |
| Est. primary completion date | June 30, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Subject is a recipient of a de novo kidney from a living or deceased donor Exclusion Criteria: - Subject has induction therapy, other than study-assigned basiliximab, planned as part of initial immunosuppressive regimen - Subject has previously received or is receiving an organ transplant other than a kidney - Subject will receive a solitary kidney from a deceased donor < 5 years of age - Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours - Subject will receive a kidney that meets both Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. Note: a kidney that meets either ECD or DCD criteria is eligible for inclusion - Subject will receive an ABO incompatible donor kidney - Subject has a current calculated panel reactive antibody (cPRA) level >50% |
| Country | Name | City | State |
|---|---|---|---|
| United States | Site US10017 | Ann Arbor | Michigan |
| United States | Site US10007 | Atlanta | Georgia |
| United States | Site US10041 | Augusta | Georgia |
| United States | Site US10013 | Aurora | Colorado |
| United States | Site US10014 | Baltimore | Maryland |
| United States | Site US10006 | Birmingham | Alabama |
| United States | Site US10019 | Bronx | New York |
| United States | Site US10031 | Buffalo | New York |
| United States | Site US10036 | Chapel Hill | North Carolina |
| United States | Site US10012 | Charleston | South Carolina |
| United States | Site US10042 | Charlotte | North Carolina |
| United States | Site US10020 | Charlottesville | Virginia |
| United States | Site US10010 | Chicago | Illinois |
| United States | Site US10018 | Chicago | Illinois |
| United States | Site US10037 | Chicago | Illinois |
| United States | Site US10009 | Cincinnati | Ohio |
| United States | Site US10032 | Cleveland | Ohio |
| United States | Site US10040 | Cleveland | Ohio |
| United States | Site US10001 | Dallas | Texas |
| United States | Site US10016 | Durham | North Carolina |
| United States | Site US10002 | Fort Worth | Texas |
| United States | Site US10026 | Greenville | North Carolina |
| United States | Site US10027 | Harrisburg | Pennsylvania |
| United States | Site US10029 | Houston | Texas |
| United States | Site US10044 | Houston | Texas |
| United States | Site US10015 | Lexington | Kentucky |
| United States | Site US10022 | Livingston | New Jersey |
| United States | Site US10008 | Los Angeles | California |
| United States | Site US10005 | Madison | Wisconsin |
| United States | Site US10028 | Memphis | Tennessee |
| United States | Site US10035 | Nashville | Tennessee |
| United States | Site US10045 | New Orleans | Louisiana |
| United States | Site US10023 | New York | New York |
| United States | Site US10034 | New York | New York |
| United States | Site US10021 | Palo Alto | California |
| United States | Site US10024 | Phoenix | Arizona |
| United States | Site US10038 | Pittsburgh | Pennsylvania |
| United States | Site US10025 | Saint Louis | Missouri |
| United States | Site US10033 | Salt Lake City | Utah |
| United States | Site US10030 | San Diego | California |
| United States | Site US10003 | San Francisco | California |
| United States | Site US10004 | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Global Development, Inc. | Kyowa Kirin Co., Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade = 1) by local review | 6 months | ||
| Secondary | Glomerular Filtration Rate (GFR) | GFR is based on Modification of Diet in Renal Disease (4 variable-MDRD) criteria | 6 months | |
| Secondary | Patient Survival | Subject survival is defined as any subject who does not die during the study. | 6 months | |
| Secondary | Graft Survival | Graft survival is defined as any subject who does not experience graft loss during the study. Graft loss is defined as subject death, retransplantation, transplant nephrectomy, or the permanent return to dialysis (greater than 30 days). | 6 months |
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